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The document outlines the guidelines for medical device certification under the Drugs and Cosmetics Act enforced by CDSCO, including device classification based on risk levels from Class A (low risk) to Class D (high risk). It details the necessary documentation for manufacturing licenses, testing licenses, and import licenses, as well as requirements for clinical investigations. Key documents include ISO 13485, device master files, and compliance with GCP and ICMR guidelines.

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22 views1 page

Untitled Document

The document outlines the guidelines for medical device certification under the Drugs and Cosmetics Act enforced by CDSCO, including device classification based on risk levels from Class A (low risk) to Class D (high risk). It details the necessary documentation for manufacturing licenses, testing licenses, and import licenses, as well as requirements for clinical investigations. Key documents include ISO 13485, device master files, and compliance with GCP and ICMR guidelines.

Uploaded by

Divith
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Guidelines for medical device certification

1. Regulations: medical devices rules under drugs and cosmetics act enforced by
cdsco.
2. Medical device classification:

Class Risk Inspected by

Class A low risk Notified body

Class B low to moderate risk CDSCO or SLA+ Notified body

Class C moderate risk CDSCO joint inspection team

Class D high risk CDSCO joint inspection team

[Link] licences: Documents required;


● ISO 13485
● Device master file
● QMS procedures
● Product testing reports from NABl
● Labels and Instruction for use
APPLICATION FOR MANUFACTURING MD-3

4. Test Licence: For testing the medical devices MD-12

5. Import licence: Requirement,


● Indian Agent
● Drug master file
● Plant master file
● Free sale certificate
● MD-14 application

[Link] Investigation:
● MD-22
● GCP
● ICMR
● Schedule Y guidelines

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